NCT03402841 — consolidated Schedule of Activities

usdm_data · 2 tables · 25 activities (24% compression) · 9 columns · study-schedule-consolidated v1.0 · Layer 3
Activities:
Near match across tables
Near match, different parent
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Common
▼ Main Schedule (9 columns)
ActivityInTable 1Table 2
Day
[study_day] L1		Before screening period-28 to -123Visit No. 4 and subsequent tumour assessment visits9Visit No. 5 and subsequent safety visits (For the first 12 months only)9Study treatment discontinuedFollow up 30 days after last dose of study medicationLong-term follow up
Day
[study_day] L2		129On the first day of next visit period (V4 = Day 57 and thereafter every 8 weeks for the first 12 months; every 12 weeks thereafter)On the first day of next visit period (V5=Day 85) and thereafter every 8 weeks)
Visit Window
[window] L3		0±3d±7d±3d±7d+7d
Informed consentT1X
IVRS/IWRS unique patient number obtainedT1X
DemographicsT1X
Medical and surgical historyT1X
Prior cancer therapies including radiotherapy, best response to prior chemotherapy regimenT1X
History of blood transfusions1T1X
Inclusion/exclusion criteriaT1X
ECOG performance statusT1,T2XXXX
Physical examination11T1,T2XX10
Vital signs (includes blood pressure, pulse and temperature), body weight11T1,T2XX10
Haematology / clinical chemistry2,7,12T1,T2XX10XXXXX
Urinalysis11T1,T2XX10
Pregnancy test for women of childbearing potential3,13T1,T2XXXXXX
Confirmed as having non-Germline BRCA Mutated ovarian cancer4T1X
Tumour assessment5,6,14T1,T2XX
AEs (from time of consent)16T1,T2XXXXXXX
Concomitant medicationsT1X
Archival or fresh tumour biopsy sample for post treatment analysis confirmation of HRD status8T1XX
Blood sample for ctDNAT2XX
Blood sample for restrospective gBRCA test15T2X
FACT-O and EQ-5D-5L questionnairesT2XXXXX
Concomitant medications including blood transfusionsT2XXXXXX
Olaparib dispensed/returnedT2XX17X17X
Subsequent cancer therapy following discontinuation of study treatment18T2XX
Time to subsequent therapy and Survival19T2X
▼ Matches across tables all 4 decided
Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT03402841_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.
staterowconsolidationother rowactivitydecision
decided · ccorr-002 merge T2 act-002 Vital signs, body weight (includes blood pressure, pulse and temperature) merged with 1.00 T1 act-010 Vital signs (includes blood pressure, pulse and temperature), body weight xact-010 Same words in another order. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-003 merge T2 act-006 Pregnancy test merged with 1.00 T1 act-013 Pregnancy test for women of childbearing potential xact-013 Table 2 footnote e on the row says the tests are for women of childbearing potential. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-001 keep T2 act-010 AEs merged with 1.00 T1 act-016 AEs (from time of consent) xact-016 Same row; the parenthesis in Table 1 is a timing remark. Kerstin Forsberg, 2026-10-04T08:20:00Z
decided · ccorr-004 keep T2 act-012 Concomitant medications including blood transfusions kept separate from 0.76 T1 act-017 Concomitant medications xact-022 Table 2 adds blood transfusions. Kerstin Forsberg, 2026-10-04T08:20:00Z
Draft — entries to append to consolidated/NCT03402841_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-04T08:21:19.786692+00:00
source_activity_count33
unified_activity_count25
compression_percent24
match_statsexact: 5, fuzzy_auto: 1, decision: 2, new: 25
▼ Source Tables 2 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Study Schedule – Screening (Visit 1)
Screening procedures (Visit 1)		 18 2 1
T2 main_soa Study Plan Detailing the Procedures
On-study treatment and follow-up schedule (Visit 2 onwards)		 15 7 3
▼ Property Hierarchy Comparison 2 main timeline tables, 3 levels max

Compares main timeline tables only (main_soa, continuation, subsidiary). Track, domain, and reference tables excluded — different structure by design.

LevelT1T2Conclusion
L1
Day
[study_day]
Only header row: timing of screening procedures relative to Day 1 ('Before screening period', '-28 to -1'). Labelled 'Day' in the source and the second value is a day range, so study_day.
Visit Number or type
[visit]
Visit numbers (2, 3) and visit types (Visit No. 4 and subsequent tumour assessment visits, Visit No. 5 and subsequent safety visits, Study treatment discontinued, 30-day follow up, Long-term follow up); named visits, so visit.
≠ Differs
L2—
Day
[study_day]
Study day of each visit (1, 29, recurring-visit day rules for V4+/V5+); empty for event-driven columns. Labelled 'Day', so study_day.
1/2 tables
L3—
Visit Window
[window]
Allowed visit windows (0, ±3d, ±7d, +7d); empty for Long-term follow up. Window values, so window.
1/2 tables
▼ Unified Activities 25 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Informed consent one table 1 T1
xact-002 IVRS/IWRS unique patient number obtained one table 1 T1
xact-003 Demographics one table 1 T1
xact-004 Medical and surgical history one table 1 T1
xact-005 Prior cancer therapies including radiotherapy, best response to prior chemotherapy regimen one table 1 T1
xact-006 History of blood transfusions one table 1 T1
xact-007 Inclusion/exclusion criteria one table 1 T1
xact-008 ECOG performance status same name 2 T1, T2
xact-009 Physical examination same name 2 T1, T2
xact-010 Vital signs (includes blood pressure, pulse and temperature), body weight
≈ Vital signs, body weight (includes blood pressure, pulse and temperature)		 merged by decision 2 T1, T2
xact-011 Haematology / clinical chemistry same name 2 T1, T2
xact-012 Urinalysis same name 2 T1, T2
xact-013 Pregnancy test for women of childbearing potential
≈ Pregnancy test		 merged by decision 2 T1, T2
xact-014 Confirmed as having non-Germline BRCA Mutated ovarian cancer one table 1 T1
xact-015 Tumour assessment same name 2 T1, T2
xact-016 AEs (from time of consent)
≈ AEs		 near match, accepted 2 T1, T2
xact-017 Concomitant medications one table 1 T1
xact-018 Archival or fresh tumour biopsy sample for post treatment analysis confirmation of HRD status one table 1 T1
xact-019 Blood sample for ctDNA one table 1 T2
xact-020 Blood sample for restrospective gBRCA test one table 1 T2
xact-021 FACT-O and EQ-5D-5L questionnaires one table 1 T2
xact-022 Concomitant medications including blood transfusions one table 1 T2
xact-023 Olaparib dispensed/returned one table 1 T2
xact-024 Subsequent cancer therapy following discontinuation of study treatment one table 1 T2
xact-025 Time to subsequent therapy and Survival one table 1 T2
▼ Unified Annotations 19 annotations (0% dedup from 19)
Footnote (19)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Include history of blood transfusion within previous 120 days from start of study treatment and the reasons, e.g., bleeding or myelosuppression. History of blood transfusions
xannot-002 2 T1:b 1 Coagulation test should be performed if clinically indicated. For a list of all required laboratory tests please refer to Section 5.2.1. Haematology / clinical chemistry Section 5.2.1
xannot-003 3 T1:c 1 Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to starting treatment and a confirmatory test before treatment on Day 1. If results are positive, the patient is ineligible/must be discontinued from the study. Pregnancy test for women of childbearing potential
xannot-004 4 T1:d 1 Patients must be non-germline BRCA mutated to be enrolled into the study. Patients for whom their gBRCA status is already known should be consented to the study within 28 days prior to Day 1 of study treatment. Patients who do not know their mutation status will need BRCA1/2 mutation screening (see Section 4.1.1 and Appendix F). Confirmed as having non-Germline BRCA Mutated ovarian cancer Section 4.1.1 · Appendix F
xannot-005 5 T1:e 1 Includes CA-125 measurement where required (Refer to Inclusion Criterion 6). RECIST assessment should be performed no more than 28 days before the start of study treatment, and ideally should be performed as close as possible to the start of study treatment. Tumour assessment
xannot-006 6 T1:n1 1 Note: MRI/ CT scan more than 28 days prior to Day 1 may be acceptable, please consult with AstraZeneca. Tumour assessment
xannot-007 7 T1:f 1 These measurements may be repeated within the screening period if abnormalities are found which are the only reason for screen failing the patient and which can reasonably be expected to have return to the acceptable range Haematology / clinical chemistry
xannot-008 8 T1:g 1 All patients are required to submit either an archival tumour sample, or a fresh biopsy if an archival sample is not available, for retrospective testing of their genetic status. If archival tissue, the presence of adequate tissue needs to be confirmed prior to screening, but it will not be shipped to the central lab before Day1. If fresh, the biopsy should be taken after the baseline scan has been performed. Samples should be submitted as paraffin blocks, alternatively, sections mounted on glass slides prepared from the block can be provided. Please refer to the laboratory manual for further details regarding tissue collection, shipping and storage. Archival or fresh tumour biopsy sample for post treatment analysis confirmation of HRD status
xannot-009 9 T2:a 1 From Visit 3 onwards, visits will take place on the first day of each 4-week visit period, relative to the date of the first olaparib dose (if the patient has not progressed and is still on treatment). Where the visit does not coincide with tumour assessment visits, these safety visits will only be for laboratory and pregnancy testing and recording of ECOG status, AEs and concomitant medication including transfusions. Where these visits coincide with tumour assessments, the assessment visit schedule will be performed Visit No. 5 and subsequent safety visits (For the first 12 months only) | Visit No. 4 and subsequent tumour assessment visits
xannot-010 10 T2:b 1 If assessed within 7 days before first dose and meets the stated eligibility criteria (if applicable), it does not need to be repeated on Day 1 of study treatment unless Investigator believes that it is likely to have changed significantly. Physical examination | Vital signs (includes blood pressure, pulse and temperature), body weight | Haematology / clinical chemistry (+1) 4 cells
xannot-011 11 T2:c 1 To be additionally performed if clinically indicated at any other time. Physical examination | Vital signs (includes blood pressure, pulse and temperature), body weight | Urinalysis
xannot-012 12 T2:d 1 All samples should be taken prior to first dose. Coagulation test should be performed if clinically indicated. For a list of all required laboratory tests please refer to Section 5.2.1. Haematology / clinical chemistry Section 5.2.1
xannot-013 13 T2:e 1 Pregnancy tests on blood or urine samples will be performed for women of childbearing potential within 28 days prior to the start of study treatment, on Day 1 of the study prior to commencing treatment, at the time points shown in Table 2 during study treatment and at the 30-day follow-up visit. If results are positive the patient is ineligible/must be discontinued from study treatment immediately. Pregnancy test for women of childbearing potential Table 2
xannot-014 14 T2:f 1 Visit 4 onwards: Subsequent tumour assessments will be conducted every 8 weeks (±7 days) for the first 12 months and then every 12 weeks (± 7 days) until documented disease progression. Tumour assessment
xannot-015 15 T2:g 1 Unless patient was tested at Myriad as part of screening. All patients are required to provide a 9 ml blood sample for confirmation of gBRCA status. Please refer to the laboratory manual for further details regarding blood sample collection,shipping and storage. Blood sample for restrospective gBRCA test
xannot-016 16 T2:h 1 All ongoing AEs/SAEs and any new AEs/SAEs identified during the 30 calendar days follow-up period after last dose of study medication must be followed to resolution. AEs (from time of consent)
xannot-017 17 T2:j 1 +/- 2 days visit window allowed for the dispensing. Sufficient study treatment should be dispensed for at least each treatment period plus overage; however, additional treatment can be dispensed to patients to last longer if required. Olaparib dispensed/returned 2 cells
xannot-018 18 T2:k 1 Start date of the first anticancer treatments (including, but not limited to, chemotherapy and targeted agents), following discontinuation from study treatment must be recorded. Subsequent cancer therapy following discontinuation of study treatment
xannot-019 19 T2:l 1 Patient will be followed (can be by phone or email) regularly until start of subsequent therapy; survival will be followed at approximately 12 weekly intervals thereafter. Time to subsequent therapy and Survival